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PHARMACEUTICAL INDUSTRY:
Clinical Trials Budget, Cost and Resource Management Six Sigma Process Improvement
 Client:

Clinical Operations Division of a global pharmaceutical company.
 Problem:  The clinical trials Budget, Cost and Resource Management processes were performing poorly requiring extensive effort to manage, producing large deviations from forecasts and sub-optimizing staff skills. Reducing process variation was a key goal for the project. It was also important to provide clinical operations personnel with the skills and process improvement methods needed to improve other processes in the future.

 Approach:  Six Sigma methodology was used to achieve the goals of this project. The project was divided into 6 sub-projects to be lead by 14 Green Belts: Initial Trial Budget, Trial Budget Update, Latest Estimate for Trial, Update and Review of Actual Costs, FTE Internal Resource Forecasting, Invoice Payments Process. All of the Green Belts were trained in Six Sigma Process Improvement methodology as they worked on their projects. The GBs were assigned to the sub-projects in groups of two or three. A team of 2-7 persons worked on each sub-project. In some instances, people with special expertise were added to the teams as ad hoc members. In total more than 25 people worked as sub-team members. Each GB also had a Champion who provided guidance and mentoring. Monthly progress reports and a final report were made to the Steering Team. The GBs and sub-team members worked part-time on their projects, meeting 2-4 times per month.

 Results:   Thirteen process improvements and 13 system/technology changes/improvements were made, resulting in an estimated $2.2 million in cost avoidance. Implementation plans, including training plans, stakeholder agreements and process control plans, were created for all process improvements and system/technology changes/improvements. Other benefits realized by the organization include:10 Certified GB who are skilled in Six Sigma process improvement methods have successfully completed their GB projects and are ready to lead future improvement projects, and the Steering Team and a cadre of Champions are now experienced in how to support a Six Sigma project.